Supply Chain Integrity Featured Articles
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Implementing A Vendor Oversight Quality Management System: Insights From Biogen Idec Data Management
11/21/2014
As the volume and complexity of outsourcing increases, it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, following GCP-compliant processes and have adequate controls in place to ensure patient safety and data integrity.
Unfortunately, it is also common for silos to exist in many large organizations. Much of what the data management area might do is contained within that department. What the clinical operations department does might be confined to clinical operations. As a result, not all information generated on vendor interactions will be passed through all of the functional areas requiring access to the information.
When those regulatory inspectors do show up at your door, it is not uncommon for them to ask “what have you done to oversee this vendor?” or “what evidence of vendor oversight can you produce?” As the sponsor is ultimately accountable for the quality of the data and the study conduct, it is important to ensure that oversight is applied throughout the lifecycle of the study. At the same time, it is important to not duplicate effort, micromanage the vendor, or fix issues that should be resolved by the vendor. Oversight is essential, but spending time on unnecessary activities can have the effect of decreasing quality.
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Reducing Clinical Costs With The Right Drug Distribution Strategy
11/21/2014
Can having the right drug distribution strategy help to significantly reduce the cost of clinical trials? A study conducted by eClipseCRO has shown that it can, with quite impressive results. The study, released earlier this year, was designed to provide a comparative analysis between two identical Phase 3 studies, each with a total enrollment of 300 patients. According to Leslie Bihari, president and CEO of eClipseCRO, both studies were conducted with identical study designs, drug administration schedules, clinical technologies, and sites. The only variation in the studies was due to persistence of the disease condition (chronic versus acute) and the strategy used for the packaging and delivery of the drugs.
“One of our goals in comparing the two studies was to figure out a way to bring down the overall cost,” says Bihari. “But at the same time we saw the opportunity to use technology to also improve both product quality and patient safety. Those were the critical factors on which we focused.”
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The Supply Chain Of The Future: A Strategic View
8/26/2014
Evolutionary theory teaches us it is neither the strongest nor the most intelligent of the species that survives. It is the one that is the most adaptable to change. Peter Bigelow, president of xcell Strategic Consulting, likes to mention this quote, widely attributed to Charles Darwin, when opening presentations on the future of the pharmaceutical supply chain. Ingredient suppliers, manufacturers, quality standards and audits, and logistics are just a few areas where we can expect to see many changes going forward. Adapting to these changes will be critical to everyone involved in the process, and in ensuring medicines are delivered to patients safely and effectively.
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API Manufacturing: Alive And Well In The U.S.
6/25/2013
Dr. Stephen Munk, president and CEO of API manufacturer Ash Stevens, had been taking Lipitor for years. But when his insurance company mandated a generic version of the drug, he was switched to one produced by Ranbaxy Laboratories, a manufacturer based in India. In November Munk learned that glass shards were found in the product. “I went to my pharmacy and told them I wasn’t happy about glass particles showing up in a drug I was taking,” he says. “They told me the FDA had not issued any guidance on it, so don’t worry about it. The entire incident was just further proof to me that U.S. API manufacturing was poised for significant growth.”
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Quality By Design, Should Pharma & Biotech Suppliers Be Ready?
1/31/2013
Quality by design, oh my … is it salvation or mere vexation for manufacturing and other suppliers to pharma and biotech companies — or something else entirely?
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Save Time, Money, And Improve Supply Chain Management With E-Procurement
12/7/2011
If your staff is using a manual, paper-based procurement system, they probably search through stacks of catalogs and visit multiple websites for the products they need. By Karl Schmieder, contributing editor
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Refinement Of Industry Guidance Promotes Harmonization Of Good Distribution Practices ... But Gaps Remain
11/1/2011
It is an exciting time for those with an interest in the pharma cold chain. While change may cause uncertainty, for those engaged in the heavily regulated healthcare industry, the ongoing refinement of guidance further clarifies the regulatory requirements for the storage and distribution of temperature-sensitive products. By Chris Fore
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5 Key Questions & Answers Regarding Pharmacovigilance
9/29/2011
A Q&A with Sanket Agrawal, executive director, global regulatory affairs and safety, at Amgen, and Nagaraja Srivatsan, senior VP, head of life sciences, North America, Cognizant Technology Solutions.
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The Challenges Of A Supply Chain Manager In An Evolving Clinical Landscape
9/7/2011
Effectively planning and executing a successful clinical supply chain is a complex task inundated with key decision points that have significant consequences for a clinical trial.
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Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain
With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.